Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of 2 doses of live attenuated varicella vaccine

Conditions: Varicella

Summary: the purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(gmts) of 2 doses of live attenuated varicella vaccine.


Eligibility criteria:
inclusion criteria: * parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent * participant is aged ≥ 1 year to ≤ 7 years * participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster * subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures * body temperature ≤ 37.5℃ exclusion criteria: * known allergy to any constituent of the vaccine * known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction * failed to the expanded programme on immunization(epi) * receipt of any vaccine in the 4 weeks preceding the trial vaccination * plan to receive any vaccine in the 4 weeks following the trial vaccination * known bleeding disorder * receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination * reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination * an acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial * participation in any other interventional clinical trial * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
the effect of spermatic vein embolization on prostatic hypertrophy

Conditions: Varicocele

Summary: in varicocele the venous pressure in the prostatic bed is increased .this may result in raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy. restoring normal venous drainage is expected to lower hydrostatic pressure followed by inhibition of prostatic growth and possibly leading regression in prostatic dimensions.

35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy (bph)and varicocele as visualized by ultrasound and/or termography examination will be enrolled. each patient will undergo a full urologic examination to exclude possible malignancy as well as a thorough medical examination to establish eligibility for treatment. in all selected patients the varicocele will be obliterated by means of embolization of the spermatic veins. the patients will be followed every three months by abdominal ultrasound as well as by serial psa for a period of 6-12 months.

Eligibility criteria:
inclusion criteria: * male * age \> 45 \< 80 years * bph * bilateral varicocele. exclusion criteria: * coagulation disturbance * chf * malignancy * renal failure.

Keywords: varicocele
the effect of transcranial direct current stimulation on decision making and cognitive flexibility in gambling disorder

Conditions: Gambling Disorder

Summary: the investigators conducted a double-blind randomised sham-controlled study. upon enrollment into the study, participants were randomly assigned to one of two conditions: (i) active group: anodal stimulation over the right dlpfc (n = 10) or (ii) sham stimulation group (n = 10). participants and raters were blinded to the condition. subsequently, the participants were administered the igt and the wisconsin card sorting test by a trained neuropsychologist in a quiet laboratory. a computerized version of standard igt was used. the order of the tasks performed in a single session was randomised. after the psychiatric and neurocognitive assessment, participants received three sessions of 20-minute active or sham anodal tdcs (once a day, every other day). wisconsin card sorting test and a modified version of iowa gambling test were readministered after the last application. the order of the tasks was randomized again. a brief questionnaire on study blinding was also administered. safety was assessed through open-ended questions based on the tdcs adverse events questionnaire


Eligibility criteria:
inclusion criteria: * participants meeting diagnostic and statistical manual of mental disorders (dsm-5) criteria for gambling disorder * being right-handed * being 18-65 years old * being drug-free exclusion criteria: * current dsm-5 diagnosis of major depressive disorder * current or previous dsm-5 diagnosis of alcohol and substance use disorders, schizophrenia, bipolar disorder, or other psychotic disorder * drug use in the past 4 weeks of any medication with known pro-convulsant action or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers) * any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes, * the presence of mental retardation diagnosis (previously identified) * any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures * illiteracy, deficient language or refusal to participate.

Keywords: gambling disorder cognition
predictors of physical activity in adult patients with hemophilic arthropathy

Conditions: Hemophilia

Summary: introduction. the development of hemophilic arthropathy causes degenerative joint damage that leads to functional impairment, limiting physical activity and causing disability in patients with hemophilia. objectives. i) to assess the level of physical activity in patients with hemophilia; ii) to identify the best predictive model for physical activity in adult patients with hemophilic arthropathy. material and method. multicenter cross-sectional cohort study. eighty-eight patients will be recruited. the dependent variable will be physical activity (international physical activity questionnaire). secondary variables will be kinesiophobia (tampa kinesiophobia scale), functionality (functional independence scale in hemophilia), pain intensity, and clinical, anthropometric, and sociodemographic variables.


Eligibility criteria:
inclusion criteria: * patients with hemophilia a or b * over the age of majority * with a medical diagnosis of severe phenotype of the disease * with a medical diagnosis of hemophilic arthropathy in the lower limbs * under on-demand or prophylactic drug treatment. exclusion criteria: * patients who require technical aids for walking * patients who are dependent for activities of daily living * patients over the age of 60 * patients with cognitive impairments that prevent them from understanding the questionnaires

Keywords: hemophilia physical activity kinesiophobia functionality joint pain
efficacy and safety of fluvastatin in different doses in adults with mixed dyslipidemia or primary hypercholesterolemia

Conditions: Mixed Dyslipidemia; Hypercholesterolemia

Summary: the purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a chinese population. this study is not recruiting patients in the us.


Eligibility criteria:
inclusion criteria: * mixed dyslipidemia * primary hypercholesterolemia exclusion criteria: * pregnant or lactating women * age \> 18 years other protocol-defined inclusion and exclusion criteria may apply.

Keywords: mixed dyslipidemia high cholesterol adults fluvastatin
anal hsil screening algorithm

Conditions: Anal High-grade Squamous Intraepithelial Lesion

Summary: this the propose to use the multiphase optimization strategy trial (most) design to identify an anal hsil screening algorithm which is most suitable in terms of effectiveness, efficiency, and economy. specifically, the investigators will use a factorial design as the main strategy in the most, as this allows the evaluation of multiple intervention components that are candidates for ultimate inclusion in the algorithm. the investigators will then implement the most suitable anal hsil screening algorithm in the clinic, using the re-aim (reach, effectiveness, adoption, implementation, maintenance) framework to guide its design, implementation, and evaluation. an interrupted time series will be used to compare anal hsil screening uptake among men who have sex with men clients in the clinic, prior to and after the implementation of the new anal hsil screening algorithm, and mixed-methods approaches will be used to evaluate components of the re-aim framework.

i. preparation phase purpose to lay groundwork for optimization of anal high-grade squamous intraepithelial lesion screening algorithm for msm, and identify which test and component(s) should be included in the anal hsil screening algorithm. ii. optimization phase purpose to form an anal high-grade squamous intraepithelial lesion screening algorithm that meets the optimization criteria. iii. evaluation phase purpose to establish whether the optimized anal high-grade squamous intraepithelial lesion screening algorithm has a statistically significant effect on service uptake among msm compared to the standard of care.

Eligibility criteria:
inclusion criteria clients for msm and tgw: * thai nationality, men with self-identifies as msm and/or tgw * hiv-positive msm/tgw aged 30 years or older or * hiv-negative msm/tgw aged 40 years or older clinic staff: - has worked in the study clinic during phase iii government stakeholders: - involved in health policy development in thailand exclusion criteria clients for msm and tgw: * unable to perform any study procedures, or unable to commit to attend all study visits. * had anal cancer lesion at enrollment visit, this exclusion for participation in phase ii study. clinic staff: - not willing to participate in the evaluation government stakeholders: - not willing to participate in the evaluation

Keywords: anal cytology human papillomavirus(hpv) high resolution anoscopy (hra)
desflurane versus propofol in the sitting position

Conditions: Cerebral Ischemia

Summary: the investigators hypothesized that both propofol and desflurane would decrease the regional oxygen saturation (rso2) but propofol is likely to reduce rso2 more than sevoflurane when patients are raised to the sitting position.

the investigators hypothesized that both propofol and desflurane would decrease the rso2 but propofol is likely to reduce rso2 more than sevoflurane when patients are raised to the sitting position. therefore, the purpose of this study was to investigate the effect of desflurane and propofol on rso2 values during the beach chair position for shoulder arthroscopy.

Eligibility criteria:
inclusion criteria: * forty patients, * asa class i or ii, * undergoing shoulder arthroscopy exclusion criteria: * patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index \> 30) were excluded from this study.

Keywords: propofol desflurane cerebrovascular circulation sitting
comparison of standard vs. accelerated corneal crosslinking

Conditions: Keratoconus; Ectasia Corneal

Summary: the study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.


Eligibility criteria:
inclusion criteria: * documented keratoconus or ectasia after refractive surgery exclusion criteria: * insufficient corneal thickness * ocular condition that may predispose the eye to complications * history of chemical injury or delayed epithelial healing * condition that would interfere with or prolong epithelial healing * known sensitivity to treatment medications * pregnancy
pilot study to define the immune response following cryoablation of invasive breast cancer

Conditions: Invasive Ductal Carcinoma, Breast

Summary: this study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group. consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). participants will undergo a blood draw at the time of consent. those in the control arm will continue with their standard of care lumpectomy. the intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.


Eligibility criteria:
inclusion criteria: * ultrasound visible invasive ductal carcinoma (idc) diagnosed by core needle biopsy; * tumor visible by ultrasound at time of treatment; * unifocal primary disease; * tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound); * tumor depth ≥ 0.5 cm from the skin or nipple-areola complex; * planned lumpectomy exclusion criteria: * pregnant patients * multifocal or metastatic disease * planned neoadjuvant chemotherapy or radiation * extensive ductal carcinoma in situ (dcis; \>25% dcis component) either diagnosed on core biopsy or strongly suggested by imaging * known allergy to both lidocaine and benzocaine

Keywords: invasive ductal carcinoma breast cancer cryoablation
pharmacokinetics and drug interaction study between amlodipine,olmesartan and rosuvastatin in healthy adult volunteers

Conditions: Healthy

Summary: the purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 19 - 55 years * a body mass index in the range 19 - 27 kg/m2 * willingness to participate during the entire study period * written informed consent after being fully informed about the study procedures exclusion criteria: * any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease * history of clinically significant drug hypersensitivity * use of medication within 7 days before the first dose * heavy drinker (\>140 g/week) * whole blood donation during 60 days before the study * judged not eligible for study participation by investigator
assessment of gastrointestinal discomfort and infections in healthy term infants

Conditions: Gastrointestinal Symptoms; Infection; Allergy Symptoms; Growth

Summary: a retrospective observational medical dossier-based study to assess gastrointestinal discomfort and infections in healthy term infants

gastrointestinal (gi) symptoms like regurgitation, unexplained crying and stool issues (diarrhoea or constipation) are common in young infants \<4 months of age due to an immature gut epithelial barrier, immune system and microbiota, with studies indicating prevalences ranging from 25.9%-78%. this retrospective observational medical dossier-based study is designed to determine the occurrence of gi symptoms in healthy term formula-fed infants to confirm reported prevalence of mild gi symptoms by hcps in middle east (74%). as a secondary objective, the improvement of confirmed gi symptoms when switched before 4 months of age from a cmf to gmf will be determined. based on the results of a previous study in infants with confirmed gi symptoms, it is expected that fewer gi symptoms will be scored in medical dossiers of infants after switching from cmf to gmf, with hm as a reference group. other secondary objectives of this study are to explore differences between healthy term infants that were fed gmf compared to infants fed cmf or hm on immune related outcomes such as infections and allergies, medication use related to infections and/or gastrointestinal discomfort and/or allergies, number of clinic visits, adequate growth and reason of changing infant formula.

Eligibility criteria:
inclusion criteria: * either exclusively formula fed (gmf or cmf; consumption of hm ≤2 weeks is allowed for formula fed infants) or exclusively breastfed before introduction of complementary feeding. * age 12-24 months of age to ensure collection of recent data. * if required by local regulation or guidelines, written informed consent (icf) from investigator (or parent(s) and/or caregiver(s)\* aged ≥18 years). * singleton, term infants (gestational age ≥ 37 weeks and ≤ 42 weeks). * at least 6 reported visits to the doctor between 0-12 months of age. exclusion criteria: * consumed hydrolysed infant formula or other specialty formulas. * any current or previous illnesses/conditions and/or known congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement. * participation in any clinical trial during first year of life. * for formula-fed infant, no switch in feeding type after 4 months of age is allowed.

Keywords: infant retrospective medical dossier-based study gi symptoms infection symptoms allergy symptoms type of feeding growth
bacterial composition and recurrent cystitis in postmenopausal women after treatment with lactobacilli.

Conditions: Cystitis Recurrent; Lactobacillus Infection

Summary: the goal of this clinical trial is to learn about the effect on the bacterial composition in the microbiome (the body's own bacteria) of urine, vagina and faeces after treatment with lactobacilli (lactobacilli's are a part of the microbiome), and its influence on repeated cystitis in postmenopausal women. the main questions it aims to answer are: * does treatment with lactobacilli change the composition of the urine microbiome in postmenopausal women? * does treatment with lactobacilli prevent repeated cystitis in postmenopausal women? participants will be followed for 6 months. they will for 3 months receive a look-alike substance that contains no active drug and for the other 3 months tablets with lactobacilli. a computer program will decide what treatment the participant will begin with, and after 3 months she will be receiving the tablets, she did not get first. this way all participants receive both type of tablets and can be their own control. what type of tablet the participants is taking is unknown to both clinical staff and participants. the participants will come to the hospital for start-up, and every 1,5 moths for the next 6 months. they deliver * faeces sample * urine tests * vaginal swab each time they are seen. when entering the study, they also complete health care questions on medication, earlier surgery, alcohol, tobacco, childbirths, weight, height etc. they make a drinking and voiding diary 3 times over the 6 months. when the study is over, alle the samples of faeces, urine and the vaginal swab will undergo analyzation for the bacterial composition in the microbiome, and differences in the microbiome when taking lactobacilli or not will be examined. the urine sample is controlled for bacteria known to give cystitis, and the influence on repeated cystitis will also be examined.


Eligibility criteria:
inclusion criteria: * postmenopausal women * if hysterectomy before menopause, then age of \>60 years * verified diagnose of recurrent cystitis. (two in 6 months or 3 in a year, verified by cultivation) * able to speak and write danish exclusion criteria: * vaginal prolapse with symptoms * residual urine over 150 ml * bladder diseases * profylactic antibiotics * probiotics * bladder cancer * genital cancer.
vertical transmission of hepatitis c virus

Conditions: Hepatitis C; Transmission

Summary: vertical hcv transmission has been extensively studied, with a risk around 5% (range: 3 to 10%). spontaneous viral clearance in infected children during childhood can occur, but data about this phenomenon are scarse, justifying the study.

hepatitis c virus (hcv) mother-to-child transmission (mtct) has been extensively studied, with a risk around 5% (range: 3 to 10%) from chronically infected pregnant women with a positive hcv rna during pregnancy. risk factors include: hcv rna load level, hiv-hcv co-infection, duration of labour, hcv genotype, child gender, and invasive procedures either during pregnancy or at birth. hepatitis c virus (hcv) mother-to-child transmission (mtct) mainly occurs during the last trimester of pregnancy or at birth or around the birth (el-shabrawi et al., world journal of gastroenterology 2013). currently, using caesarian section to reduce the risk of hepatitis c virus (hcv) mother-to-child transmission (mtct) is still debated and not recommended in international guidelines (easl 2012). spontaneous viral clearance in infected children during childhood seems to occur in 20% of cases, with predisposing genetic factors (ruiz-extremera a et al. hepatology 2011 ; 53 : 1830-1838) but data about this phenomenon are scarse (rerksuppaphol s et al. j gastroenterol hepatol 2004), justifying the study.

Eligibility criteria:
inclusion criteria: * hcv chronically infected pregnant women * with a positive hcv rna * who gave birth in the maternity department, lariboisiere hospital, paris, france exclusion criteria: * negative hcv rna during pregnancy * acute hcv infection during pregnancy (previous negative hcv test during pregnancy) * mtct not to be tested (early child death for instance)
effect of timed-restricted eating on metabolic health

Conditions: Obesity; Non-Alcoholic Fatty Liver Disease; Insulin Resistance

Summary: we aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.

obesity is an alarming global health issue, with increasing prevalence. obesity leads to a vast array of disorders, including dyslipidemia, the accumulation of intrahepatic triglycerides (ihtg), multiorgan insulin resistance and type 2 diabetes mellitus. in addition, disruption of the circadian rhythm (circadian misalignment), which is associated with irregular eating schedules, is an important risk factor for the development of obesity, ihtg and type 2 diabetes mellitus. time restricted eating (tre) is a form of intermittent fasting, in which the daily eating period is restricted. the beneficial effect of this type of diet might relate to adequate synchronization of food intake and fasting to the internal rhythm of the circadian tissue clocks, improving metabolic handling of nutrients and metabolic flexibility.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent; * bmi \> 30kg/m\^2; * insulin resistance, as defined by fasting plasma insulin \> 62 pmol/l and/or prediabetes, as defined by fasting plasma glucose \> 5.3 and \< 7.0 mmol/l; * stable weight for 3 months prior to study inclusion * for women, 1 year after last menstrual cycle exclusion criteria: * use of any medication, except for those related to treatment of metabolic syndrome; * any medical condition interfering with study outcomes or design; * history of any psychiatric disorder, including eating disorders; * performing shift work * performing intensive sports (\>3 hours/week); * smoking; * drugs abuse or alcohol abuse (\>3 units/day); * contraindication for mri; * known lactose/gluten intolerance; * known soy, egg, milk or peanut allergy; * childhood onset of obesity